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Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients: A Randomized Clinical Trial

Ortigoza, Mila B; Yoon, Hyunah; Goldfeld, Keith S; Troxel, Andrea B; Daily, Johanna P; Wu, Yinxiang; Li, Yi; Wu, Danni; Cobb, Gia F; Baptiste, Gillian; O'Keeffe, Mary; Corpuz, Marilou O; Ostrosky-Zeichner, Luis; Amin, Amee; Zacharioudakis, Ioannis M; Jayaweera, Dushyantha T; Wu, Yanyun; Philley, Julie V; Devine, Megan S; Desruisseaux, Mahalia S; Santin, Alessandro D; Anjan, Shweta; Mathew, Reeba; Patel, Bela; Nigo, Masayuki; Upadhyay, Rabi; Kupferman, Tania; Dentino, Andrew N; Nanchal, Rahul; Merlo, Christian A; Hager, David N; Chandran, Kartik; Lai, Jonathan R; Rivera, Johanna; Bikash, Chowdhury R; Lasso, Gorka; Hilbert, Timothy P; Paroder, Monika; Asencio, Andrea A; Liu, Mengling; Petkova, Eva; Bragat, Alexander; Shaker, Reza; McPherson, David D; Sacco, Ralph L; Keller, Marla J; Grudzen, Corita R; Hochman, Judith S; Pirofski, Liise-Anne; Parameswaran, Lalitha; Corcoran, Anthony T; Rohatgi, Abhinav; Wronska, Marta W; Wu, Xinyuan; Srinivasan, Ranjini; Deng, Fang-Ming; Filardo, Thomas D; Pendse, Jay; Blaser, Simone B; Whyte, Olga; Gallagher, Jacqueline M; Thomas, Ololade E; Ramos, Danibel; Sturm-Reganato, Caroline L; Fong, Charlotte C; Daus, Ivy M; Payoen, Arianne Gisselle; Chiofolo, Joseph T; Friedman, Mark T; Wu, Ding Wen; Jacobson, Jessica L; Schneider, Jeffrey G; Sarwar, Uzma N; Wang, Henry E; Huebinger, Ryan M; Dronavalli, Goutham; Bai, Yu; Grimes, Carolyn Z; Eldin, Karen W; Umana, Virginia E; Martin, Jessica G; Heath, Timothy R; Bello, Fatimah O; Ransford, Daru Lane; Laurent-Rolle, Maudry; Shenoi, Sheela V; Akide-Ndunge, Oscar Bate; Thapa, Bipin; Peterson, Jennifer L; Knauf, Kelly; Patel, Shivani U; Cheney, Laura L; Tormey, Christopher A; Hendrickson, Jeanne E
Importance/UNASSIGNED:There is clinical equipoise for COVID-19 convalescent plasma (CCP) use in patients hospitalized with COVID-19. Objective/UNASSIGNED:To determine the safety and efficacy of CCP compared with placebo in hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen. Design, Setting, and Participants/UNASSIGNED:CONTAIN COVID-19, a randomized, double-blind, placebo-controlled trial of CCP in hospitalized adults with COVID-19, was conducted at 21 US hospitals from April 17, 2020, to March 15, 2021. The trial enrolled 941 participants who were hospitalized for 3 or less days or presented 7 or less days after symptom onset and required noninvasive oxygen supplementation. Interventions/UNASSIGNED:A unit of approximately 250 mL of CCP or equivalent volume of placebo (normal saline). Main Outcomes and Measures/UNASSIGNED:The primary outcome was participant scores on the 11-point World Health Organization (WHO) Ordinal Scale for Clinical Improvement on day 14 after randomization; the secondary outcome was WHO scores determined on day 28. Subgroups were analyzed with respect to age, baseline WHO score, concomitant medications, symptom duration, CCP SARS-CoV-2 titer, baseline SARS-CoV-2 serostatus, and enrollment quarter. Outcomes were analyzed using a bayesian proportional cumulative odds model. Efficacy of CCP was defined as a cumulative adjusted odds ratio (cOR) less than 1 and a clinically meaningful effect as cOR less than 0.8. Results/UNASSIGNED:Of 941 participants randomized (473 to placebo and 468 to CCP), 556 were men (59.1%); median age was 63 years (IQR, 52-73); 373 (39.6%) were Hispanic and 132 (14.0%) were non-Hispanic Black. The cOR for the primary outcome adjusted for site, baseline risk, WHO score, age, sex, and symptom duration was 0.94 (95% credible interval [CrI], 0.75-1.18) with posterior probability (P[cOR<1] = 72%); the cOR for the secondary adjusted outcome was 0.92 (95% CrI, 0.74-1.16; P[cOR<1] = 76%). Exploratory subgroup analyses suggested heterogeneity of treatment effect: at day 28, cORs were 0.72 (95% CrI, 0.46-1.13; P[cOR<1] = 93%) for participants enrolled in April-June 2020 and 0.65 (95% CrI, 0.41 to 1.02; P[cOR<1] = 97%) for those not receiving remdesivir and not receiving corticosteroids at randomization. Median CCP SARS-CoV-2 neutralizing titer used in April to June 2020 was 1:175 (IQR, 76-379). Any adverse events (excluding transfusion reactions) were reported for 39 (8.2%) placebo recipients and 44 (9.4%) CCP recipients (P = .57). Transfusion reactions occurred in 2 (0.4) placebo recipients and 8 (1.7) CCP recipients (P = .06). Conclusions and Relevance/UNASSIGNED:In this trial, CCP did not meet the prespecified primary and secondary outcomes for CCP efficacy. However, high-titer CCP may have benefited participants early in the pandemic when remdesivir and corticosteroids were not in use. Trial Registration/ Identifier: NCT04364737.
PMID: 34901997
ISSN: 2168-6114
CID: 5084962

Current advances in transfusion medicine 2020: A critical review of selected topics by the AABB Clinical Transfusion Medicine Committee

Allen, Elizabeth S; Cohn, Claudia S; Bakhtary, Sara; Dunbar, Nancy M; Gniadek, Thomas; Hopkins, Courtney K; Jacobson, Jessica; Lokhandwala, Parvez M; Metcalf, Ryan A; Murphy, Colin; Prochaska, Micah T; Raval, Jay S; Shan, Hua; Storch, Emily K; Pagano, Monica B
BACKGROUND:The AABB Clinical Transfusion Medicine Committee (CTMC) compiles an annual synopsis of the published literature covering important developments in the field of transfusion medicine (TM), which has been made available as a manuscript published in Transfusion since 2018. METHODS:CTMC committee members reviewed original manuscripts including TM-related topics published electronically (ahead) or in print from December 2019 to December 2020. The selection of topics and manuscripts was discussed at committee meetings and chosen based on relevance and originality. Next, committee members worked in pairs to create a synopsis of each topic, which was then reviewed by two additional committee members. The first and senior authors of this manuscript assembled the final manuscript. Although this synopsis is extensive, it is not exhaustive, and some papers may have been excluded or missed. RESULTS:The following topics are included: COVID-19 effects on the blood supply and regulatory landscape, COVID convalescent plasma, adult transfusion practices, whole blood, molecular immunohematology, pediatric TM, cellular therapy, and apheresis medicine. CONCLUSIONS:This synopsis provides easy access to relevant topics and may be useful as an educational tool.
PMID: 34423446
ISSN: 1537-2995
CID: 5004552

B subgroup detection in a small hospital transfusion service [Case Report]

Elardo, E; Elbadri, N; Sanchez, C; Powell, V; Smaris, M; Li, Y; Jacobson, J; Hilbert, T; Hamilton, T; Wu, D W
The ABO blood group system includes phenotypes, or subgroups, that differ in the amount of A and B antigens present on the red blood cells (RBCs). These subgroups also differ in the A, B, or H substances present in secretions (for individuals who have the secretor phenotype). B subgroups are very rare and are less frequently reported than A subgroups. Usually, B subgroups are discovered during serologic testing when there is a discrepancy between RBC and serum grouping results. Subgroups of B are usually identified by a reference laboratory using molecular and adsorption-elution methods. This report details a case of a young, healthy, pregnant woman with a B subgroup detected by a small transfusion service using adsorption-elution methods. Serology and genotyping of the ABO gene was performed at a reference laboratory where the serology was consistent with a B subgroup, but no changes were identified in ABO gene sequencing. It is important to correctly identify B subgroups in donors and recipients to help resolve ABO discrepancies and potentially prevent ABO incompatibility in blood transfusion, thus minimizing transfusion reactions.
PMID: 34170644
ISSN: 0894-203x
CID: 4964882

Detection and Genetic Characterization of Community-Based SARS-CoV-2 Infections - New York City, March 2020

Bushman, Dena; Alroy, Karen A; Greene, Sharon K; Keating, Page; Wahnich, Amanda; Weiss, Don; Pathela, Preeti; Harrison, Christy; Rakeman, Jennifer; Langley, Gayle; Tong, Suxiang; Tao, Ying; Uehara, Anna; Queen, Krista; Paden, Clinton R; Szymczak, Wendy; Orner, Erika P; Nori, Priya; Lai, Phi A; Jacobson, Jessica L; Singh, Harjot K; Calfee, David P; Westblade, Lars F; Vasovic, Ljiljana V; Rand, Jacob H; Liu, Dakai; Singh, Vishnu; Burns, Janice; Prasad, Nishant; Sell, Jessica
To limit introduction of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), the United States restricted travel from China on February 2, 2020, and from Europe on March 13. To determine whether local transmission of SARS-CoV-2 could be detected, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) conducted deidentified sentinel surveillance at six NYC hospital emergency departments (EDs) during March 1-20. On March 8, while testing availability for SARS-CoV-2 was still limited, DOHMH announced sustained community transmission of SARS-CoV-2 (1). At this time, twenty-six NYC residents had confirmed COVID-19, and ED visits for influenza-like illness* increased, despite decreased influenza virus circulation.† The following week, on March 15, when only seven of the 56 (13%) patients with known exposure histories had exposure outside of NYC, the level of community SARS-CoV-2 transmission status was elevated from sustained community transmission to widespread community transmission (2). Through sentinel surveillance during March 1-20, DOHMH collected 544 specimens from patients with influenza-like symptoms (ILS)§ who had negative test results for influenza and, in some instances, other respiratory pathogens.¶ All 544 specimens were tested for SARS-CoV-2 at CDC; 36 (6.6%) tested positive. Using genetic sequencing, CDC determined that the sequences of most SARS-CoV-2-positive specimens resembled those circulating in Europe, suggesting probable introductions of SARS-CoV-2 from Europe, from other U.S. locations, and local introductions from within New York. These findings demonstrate that partnering with health care facilities and developing the systems needed for rapid implementation of sentinel surveillance, coupled with capacity for genetic sequencing before an outbreak, can help inform timely containment and mitigation strategies.
PMID: 32678072
ISSN: 1545-861x
CID: 4542482

Current advances in transfusion medicine: a 2019 review of selected topics from the AABB Clinical Transfusion Medicine Committee

Pagano, Monica B; Allen, Elizabeth S; Chou, Stella T; Dunbar, Nancy M; Gniadek, Thomas; Goel, Ruchika; Harm, Sarah K; Hopkins, Courtney K; Jacobson, Jessica; Lokhandwala, Parvez M; Metcalf, Ryan A; Raval, Jay S; Schwartz, Joseph; Shan, Hua; Spinella, Philip C; Storch, Emily; Cohn, Claudia S
BACKGROUND:The AABB Clinical Transfusion Medicine Committee (CTMC) compiles an annual synopsis of the published literature covering important developments in the field of transfusion medicine (TM) for the board of director's review. This synopsis is now made available as a manuscript published in TRANSFUSION. STUDY DESIGN AND METHODS/METHODS:CTMC committee members review original manuscripts including TM-related topics published in different journals between late 2018 and 2019. The selection of topics and manuscripts are discussed at committee meetings and are chosen based on relevance and originality. After the topics and manuscripts are selected, committee members work in pairs to create a synopsis of the topics, which is then reviewed by two committee members. The first and senior authors of this manuscript assembled the final manuscript. Although this synopsis is comprehensive, it is not exhaustive, and some papers may have been excluded or missed. RESULTS:The following topics are included: infectious risks to the blood supply, iron donor studies, pre-transfusion testing interference and genotyping, cold agglutinin disease (CAD), HLA alloimmunization in platelet transfusions, patient blood management, updates to TACO and TRALI definitions, pediatric TM, and advances in apheresis medicine. CONCLUSION/CONCLUSIONS:This synopsis provides easy access to relevant topics and may be useful as an educational tool.
PMID: 32472580
ISSN: 1537-2995
CID: 4510702

Characteristics and outcomes of COVID-19 patients in New York City's public hospital system

Kalyanaraman Marcello, Roopa; Dolle, Johanna; Grami, Sheila; Adule, Richard; Li, Zeyu; Tatem, Kathleen; Anyaogu, Chinyere; Apfelroth, Stephen; Ayinla, Raji; Boma, Noella; Brady, Terence; Cosme-Thormann, Braulio F; Costarella, Roseann; Ford, Kenra; Gaither, Kecia; Jacobson, Jessica; Kanter, Marc; Kessler, Stuart; Kristal, Ross B; Lieber, Joseph J; Mukherjee, Vikramjit; Rizzo, Vincent; Rowell, Madden; Stevens, David; Sydney, Elana; Wallach, Andrew; Chokshi, Dave A; Davis, Nichola
BACKGROUND:New York City (NYC) bore the greatest burden of COVID-19 in the United States early in the pandemic. In this case series, we describe characteristics and outcomes of racially and ethnically diverse patients tested for and hospitalized with COVID-19 in New York City's public hospital system. METHODS:We reviewed the electronic health records of all patients who received a SARS-CoV-2 test between March 5 and April 9, 2020, with follow up through April 16, 2020. The primary outcomes were a positive test, hospitalization, and death. Demographics and comorbidities were also assessed. RESULTS:22254 patients were tested for SARS-CoV-2. 13442 (61%) were positive; among those, the median age was 52.7 years (interquartile range [IQR] 39.5-64.5), 7481 (56%) were male, 3518 (26%) were Black, and 4593 (34%) were Hispanic. Nearly half (4669, 46%) had at least one chronic disease (27% diabetes, 30% hypertension, and 21% cardiovascular disease). Of those testing positive, 6248 (46%) were hospitalized. The median age was 61.6 years (IQR 49.7-72.9); 3851 (62%) were male, 1950 (31%) were Black, and 2102 (34%) were Hispanic. More than half (3269, 53%) had at least one chronic disease (33% diabetes, 37% hypertension, 24% cardiovascular disease, 11% chronic kidney disease). 1724 (28%) hospitalized patients died. The median age was 71.0 years (IQR 60.0, 80.9); 1087 (63%) were male, 506 (29%) were Black, and 528 (31%) were Hispanic. Chronic diseases were common (35% diabetes, 37% hypertension, 28% cardiovascular disease, 15% chronic kidney disease). Male sex, older age, diabetes, cardiac history, and chronic kidney disease were significantly associated with testing positive, hospitalization, and death. Racial/ethnic disparities were observed across all outcomes. CONCLUSIONS AND RELEVANCE/CONCLUSIONS:This is the largest and most racially/ethnically diverse case series of patients tested and hospitalized for COVID-19 in New York City to date. Our findings highlight disparities in outcomes that can inform prevention and testing recommendations.
PMID: 33332356
ISSN: 1932-6203
CID: 4718072

Blood usage in hospitalized confirmed COVID-19 patients in a NYC hospital [Meeting Abstract]

Jacobson, J L
Background/Case Studies: The COVID-19 pandemic has altered almost everything. The first case of COVID-19 was confirmed in New York (NY) on 3/1/20. As of 6/30, there were >212,000 confirmed cases, >50,000 patients hospitalized, and >18000 confirmed and >4600 probable deaths in NYC. The governor declared a state of emergency on 3/7. Social distancing and mandatory quarantines implemented on 3/12 have resulted in dramatic reductions in the blood supply. To preserve the blood supply and available hospital beds, all elective surgery was canceled effective 3/16. I sought to assess the usage of blood products in our hospitalized confirmed and suspected COVID-19 patients. Study Design/Methods: After obtaining IRB approval, an Epic report to identify all patients, who had a positive SARS-CoV-2 PCR test result and were transfused from 3/1/20 to 6/30/20, was created to identify how many COVID-19 patients had been transfused and the number and type of blood products they received. Results/Findings: From 3/1-6/30, 993 patients tested positively for COVID-19. 1669 confirmed and suspected patients had been admitted to the hospital, 1361 had been discharged (excluding deaths), and 253 had died. Of the admitted confirmed COVID-19 patients, 121 patients were transfused at least one blood product. A massive transfusion protocol was activated on 3 patients. A total of 519 RBCs, 78 SDPs, 40 plasmas, and 15 pooled cryoprecipitate (CRYO) units were transfused to COVID-19 patients. Table 1 depicts the mean number, range, and percent of transfusions by product type administered to COVID-19 patients.
Conclusion(s): 121 COVID-19 patients were transfused a total of 652 blood products. 21.8% of all blood products during the period were transfused to COVID-19 patients. COVID-19 patients received 23.6% of RBCs, 16.8% of plasmas, 24.2% of SDPs, and 21.4% of pooled CRYO transfused in the hospital. Although their needs were only a portion of the hospital's overall blood usage, maintaining an ample blood inventory is required to support the care of COVID-19 patients especially those requiring ECMO and long-term mechanical ventilation
ISSN: 1537-2995
CID: 4782812

Pathogen reduced plasma products: a clinical practice scientific review from the AABB

Cushing, Melissa M; Pagano, Monica B; Jacobson, Jessica; Schwartz, Joseph; Grossman, Brenda J; Kleinman, Steven; Han, Miah A; Cohn, Claudia S
BACKGROUND:A small body of literature assessing the efficacy and safety of pathogen reduced (PR) plasma has been published. STUDY DESIGN AND METHODS/METHODS:An AABB committee systematically reviewed the literature and graded the clinical trial evidence with the assistance of a GRADE expert. RESULTS:Most studies identified were low quality and had a small sample size; in addition, efficacy and safety were monitored in many different ways making it difficult to quantify therapeutic benefit and risk. The data analyzed in this systematic review showed that pathogen inactivation did not adversely affect the efficacy of S/D or amotosalen plasma transfusions in any patient population studied. In addition, there were no significant safety issues for these patient populations, other than the specific contraindications noted in their respective package inserts. CONCLUSION/CONCLUSIONS:Larger, well-designed trials are needed to further evaluate the efficacy and safety of all of the PR plasma products.
PMID: 31268584
ISSN: 1537-2995
CID: 3968152

ABO/RH type distribution in a large metropolitan public health system [Meeting Abstract]

Jacobson, J L; Sorkin, L M; Ford, K
Background/Case Studies: Many in our public health system have long believed that the racially and ethnically diverse patient population we serve had a higher proportion of both O-positive and O-negative patients than was characteristic of the general US population. Although our blood supplier routinely reported that we purchased a higher percentage of O-positive and O-negative RBCs than their other customers, we did not know the ABO/Rh percentages of our patients. Poor reporting tools limited our ability to extract this type of data from our blood bank computer system. Our system recognized the need to develop better reporting tools.We sought to determine if the long held belief was correct and justified our higher percentage of O-positive and O-negative RBCs. Study Design/Methods: Reports were created to extract ABO/Rh typing results performed on type and screen (T&S) samples performed from January 1, 2017 to December 31, 2018 from our system's blood bank computer system by individual hospital and aggregated system data. The data were analyzed to evaluate our patient ABO/Rh mix to determine if the long held belief was true or false. O-positive and O-negative percentages were also compared between facilities. The percentages of O-positive and Onegative RBC purchases were assessed with regard to the patient ABO/Rh percentages. P values were calculated and evaluated using Student's t test. Results/Findings: From January 1, 2017 to December 31, 2018, 466,444 T&Ss were resulted system-wide, and we purchased 68,853 RBC units. A total of 3.3% of patients were O-negative (facility range, 2.8%-4.8%), and 49.2% were O-positive (facility range, 40.4%-58.3%). Of the RBC units, 15.4% were O-negative and 71.2% were O-positive (overall 86.9% type O). The percentage of type O RBCs purchased far exceeded the percentage of type O patients. The percentage of type O RBC purchases surpassed the percentage of type O patients (p < 0.0007 for 2017 purchases and p < 0.00008 for 2018). The percentage of type O-negative RBC purchases surpassed the percentage of type O-negative patients (p < 0.0039 for 2017 purchases and p < 0.00002 for 2018). A total of 6.9% of patients were Rhnegative. Despite communication to better monitor inventory ordering practices, there was no statistical difference between the percentage of Opositive or O-negative RBC purchases between 2017 and 2018.
Conclusion(s): Contrary to our perception, our patient population has a lower percentage of type O-negative patients (3.3%) than the general US population (6.6%). Our patients are also less likely to be Rh-negative (6.9%; range, 5.3%-13.4%) than the US population (15.0%). Our percentage of type O-positive patients (49.2%) is higher than that of the general US population (37.4%) and more closely resembles the type O-positive rates reported in many African, Central American, and Asian countries from which many of our patients come. Antigen-negative RBCs were only 5.0% of all RBCs purchased and thus cannot alone explain the high type O RBC rate. Our system, including five Level 1 trauma centers, should be able to safely reduce our ordering of O-negative RBCs without negatively impacting patient safety. Access to timely reporting tools should help us drive change
ISSN: 1537-2995
CID: 4109652

Subgroup B detection in a small hospital transfusion service [Meeting Abstract]

Elardo, E; Sanchez, C; Powell, V; Smaris, M; Li, Y; Jacobson, J; Hilbert, T; Hamilton, T; Wu, D
Background: An ABO blood group subtype is called a subgroup and/or variant. Subgroups of ABO are often distinguished by decreased amounts of A, B or O (H) antigens on red blood cells. Blood type A appears to have the most variation in subgroups. In general, serologic distinction between A1 and other subgroups of A is based on the ability of anti- A1 lectin (an extract of Dolichos biflorus seeds) to agglutinate A1 red blood cells (RBC) but not cells of other A subgroups. As A2 is most common A subtype and is frequently detected at regular hospital transfusion services. Definitive identification of ABO subgroups is usually performed at a reference laboratory using molecular techniques and special immunohematology methods. Here we report an interesting case where a subgroup B was detected by an astute technologist using manual immunohematology tests and conventional reagents at our hospital transfusion service. Our hospital transfusion service received a blood specimen requesting a type and screen from a pregnant woman with no known medical problems. Testing the specimen showed a front type of O and a back type of B, with a negative antibody screening.
Aim(s): To resolve the typing discrepancy and to correctly Identify the ABO blood type of the pregnant patient.
Method(s): In an attempt to enhance the typing reactions with the patient's RBCs and plasma, mixtures of the front typing and back typing were incubated separately for 15 minutes at room temperature. This however did not result in any change in reactivity. The technologist became suspicious of a possible B subgroup as this was a healthy young woman and it would be rare for such a young patient to exhibit missing antibodies in the reverse type. He then performed a DAT on the specimen to assure that nothing was coating the patient's RBCs which might interfere with further testing. The DAT was negative for IgG and C3d. He subsequently performed an absorption on vigorously washed patient RBC) with anti-B reagent from Ortho. The reaction mixture was incubated at room temperature (RT) for 15 minutes, followed by an elution. The eluate was added to washed A cells, B cells, and screening cells (Ortho), and then incubated at room temperature for 15 minutes. The mixtures were washed with eluate washing solution. Anti-IgG Coombs reagent was added, the tubes were centrifuged, and results were recorded.
Result(s): A cells: Negative B cells: 2 + Screen cell #1: negative Screen cell #2: negative Screen cell #3: negative Summary/Conclusions: Based on the manual tests the technologist designed and performed, he was able to demonstrate the 2 + reactivity with type B reagent RBCs and concluded that the patient's blood type is a B subgroup. The patient's specimen was then sent to New York Blood Center Immunohematology Reference Laboratory for further confirmation and identification. The B group of the patient's RBCs was not detectable again by the conventional immunohematology tests. Molecular tests (PCR-RFLP) and full gene sequencing were performed. A B allele (*B1.01) and an O1 allele (*O1.09) were identified, which predicts a B weak subtype. The molecular testing confirms the conclusion made by our technologist using conventional manual immunohematology tests
ISSN: 1423-0410
CID: 4784112